IMS® DIAREG Diabetes Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by IMS HEALTH GmbH & Co. OHG
Sponsor:
Information provided by (Responsible Party):
IMS HEALTH GmbH & Co. OHG
ClinicalTrials.gov Identifier:
NCT01906294
First received: July 15, 2013
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

This observation plan outlines the approach to build a diabetes registry to collect data on daily routine of treatment of Type 2 Diabetes Mellitus.


Condition Intervention
Type 2 Diabetes Mellitus
Drug: antidiabetic treatment (ATC A10B)

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Prospective Diabetes Registry of Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by IMS HEALTH GmbH & Co. OHG:

Primary Outcome Measures:
  • routine treatment data (composite of e.g. diagnostics, kind and dosage of pharmacological diabetes treatment) [ Time Frame: From date of registration every 3 months until end of study (up to 120 months) ] [ Designated as safety issue: No ]
    The objective of the project is to develop a sustainable Type 2 Diabetes Mellitus (T2DM) registry to collect daily routine treatment data (e.g. diagnostics, kind and dosage of pharmacological diabetes treatment) to provide a better understanding of the disease specific epidemiology, treatment patterns, patient relevant outcomes, patient subgroups, specifically among patients with Type 2 Diabetes Mellitus. Further DDG ("Deutsche Diabetes Gesellschaft") guideline adherence and economic aspects of diabetes treatment should be evaluated on the basis of this registry data.


Estimated Enrollment: 12000
Study Start Date: August 2013
Estimated Study Completion Date: September 2023
Estimated Primary Completion Date: September 2023 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Type 2 Diabetes Mellitus
Patients with antidiabetic treatment for Type 2 Diabetes Mellitus
Drug: antidiabetic treatment (ATC A10B)

Detailed Description:

The choice to establish such a (general and specific) disease patient registry was based on several scientific and practical considerations as described in the AHRQ user's guide: registries for evaluating patient outcomes (www.ahrq.gov, 2007). From a public health point of view, such a register should monitor naturalistic (i.e., unbiased) use of diabetes treatment in the community and should primarily guide and assist medical professionals to make optimal choices in combating diabetes. The primary focus of this registry is therefore to monitor the medical and lifestyle treatment of diabetes in order to enable comparison of different treatment options and to provide data for future discussions of optimal treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with Type 2 Diabetes Mellitus

Criteria

Inclusion Criteria:

  • Provision of signed written informed consent
  • Age of 18 years or older
  • Diagnosis of Type 2 Diabetes Mellitus (T2DM)

Exclusion Criteria:

Only patients who don't fulfill the inclusion criteria will be excluded. There will be no further possibility for the treating physician to exclude individual patients.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01906294

Contacts
Contact: Kerstin Bode-Greuel, Dr. med. +49 69 6604 ext 4637 KBode-Greuel@de.imshealth.com

Locations
Germany
Praxis Dr. med. Birgit Böttger Recruiting
Frankfurt am Main, Germany, 60325
Contact: Birgit Böttger, Dr. med.    069 74 86 ext 86    b.boettger@telemed.de   
Principal Investigator: Birgit Böttger, Dr. med.         
Sponsors and Collaborators
IMS HEALTH GmbH & Co. OHG
Investigators
Study Chair: Stephan Martin, Prof. Dr. Verbund der Katholischen Kliniken Düsseldorf (VKKD) Westdeutschen Diabetes- und Gesundheitszentrum (WDGZ)
  More Information

No publications provided

Responsible Party: IMS HEALTH GmbH & Co. OHG
ClinicalTrials.gov Identifier: NCT01906294     History of Changes
Other Study ID Numbers: 5050000
Study First Received: July 15, 2013
Last Updated: October 30, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by IMS HEALTH GmbH & Co. OHG:
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014